The present invention relates to a closed system mouthpiece with light and heat generation to activate a formulation to increase its volume.
Most natural environments harbor an incredibly diverse collection of microbial species. Within these communities, bacteria compete with their neighbors for space and resources.
The mouth is no different, with a warm, nutrient rich environment, continuously bathed with saliva, and with a pH normally between 6.75-7.25, essentially neutral between acidic and basic. The oral cavity is a home for around 600 species and 8 billion bacteria all living together and vying for nutrients and resources to feed themselves, most of which are beneficial organisms and live in harmony with each other and the host.
How do all of these bacteria in one's mouth live together over time to maintain this natural healthy balance between good bacteria and the bad bacteria. Survival is key and the natural selection theory holds true over time. The microbiological community figures out how to live together, and not only survive, but to thrive in this natural ecosystem. The ability to work together and share the resources in their community is referred to as homeostasis, a balancing act that lives in our mouth in spite of numerous external changes.
However, when the external changes are too powerful for the homeostatic balance, the bacterial balance in the mouth shifts significantly. The bacteria that can cause harm begin to dominate the beneficial organisms. That is, shifts in the environment can throw the balance off between bacteria that have a positive effect vs. bacteria that cause disease. The three main environmental shifts are the pH of the mouth (acid and base balance), the availability of nutrients (food and resources) in our mouths, and how well we are cleaning the plaque off our teeth and gums; especially in the hard to reach places.
It is not the individual bacteria alone that cause disease, but the environment in our mouth that is altered by our diet and our ability to control plaque, both events we control by our daily actions. These actions directly affect the environmental circumstances in regulating and controlling the quality of the biofilm (bacterial plaque) in our mouths, the types of nutrients we put into our mouths, and the resulting pH.
For people who have a diet high in proteins (i.e., meat, processed foods) and simple carbohydrates or sugars, a low pH unhealthy, acidic environment is formed. This helps the acid tolerating bacteria like s. mutans that cause disease and displaces the oral-health associated, neutral pH bacteria such as s. salivarius. Another example of this phenomenon is the gram-negative anaerobic bacteria that also thrive in the more acidic environment that causes an inflammatory cascade to occur in the periodontal tissues and resulting gingivitis. Similarly, the bad breath causing bacteria that live in between the teeth and in the deep surfaces of the tongue also thrive in the acidic environment that decreases saliva flow and increases colonization of the harmful bacteria. So, by having a lower pH in our mouths because of what we put in our mouths and due to our food selection, the bacteria that cause decay, gum disease and bad breath start dominating the healthy bacteria. Couple this with poor plaque control, and the environment is now created for a shift in the bacterial populations to disease producing organisms and a bacterial load that not only impacts oral health, but overall health as well.
Today, the link between pathogenic bacteria originating in the oral cavity causing inflammation in other areas of the body has been scientifically demonstrated.
Dr. Han and her co-investigators have begun identifying the mechanisms that allow F. nucleatum to move from the mouth into the bloodstream and throughout the body—taking other bacteria with it and leaving destruction in their path (Molecular Microbiology, December 2011, Vol. 82:6, pp. 1468-1480). Her team has shown that F. nucleatum can induce preterm birth and stillbirth in animals and humans (see, for example, Obstetrics & Gynecology, February 2010, Vol. 115: suppl 2, part 2, pp. 442-445). Other researchers have linked this phenomenon to colorectal cancer (Genome Research, Oct. 18, 2011) and infections and abscesses in all the internal organs, including in the brain and lungs.
By controlling pH to maintain it within desirable limits, it is possible to alter the plaque biofilm, remineralize existing lesions and help prevent oral disease going forward.
Plaque is a very sticky substance that forms on the teeth in a matter of minutes and causes gum inflammation in a matter of days if the plaque is not timely removed. The areas in the mouth that are difficult to clean are the surfaces of the tongue and areas between the teeth that create an anaerobic environment. Without oxygen, the bacteria that cause bad breath and periodontal disease now colonize if they are not timely removed. If we look at ways to mitigate the dominance of the bad bacteria over the healthy ones, if we can impact the pH of our mouths and effectively decrease the bad bacteria in the mouth, we will have an effective way to promote good health in the mouth. The objective is to change the environment from oxygen poor-low pH sites where the pathogenic bacteria thrive to a safer, more effective way to rebalance homeostasis in the mouth toward enhanced health with an oxygen-rich-higher ph.
We know that only 10% of the population flosses regularly and that 75% of the population over the age of 35 has some form of gum disease. The latest data from the NIH and the Academy of Periodontics is that half the adult population has some form of periodontal disease, which is gum inflammation along with bone loss. These chronic type lesions are the ones that show an increase in bacterial load in the mouth which impacts areas all over the body as the oral disease bacteria have the chance to be disseminated to other areas in the body. The connection between oral health and overall health is an emerging science of oral systemic medicine and has been growing over the last decade. Moise Desvarieux, an infectious disease epidemiologist at Columbia University, conducted studies showing the link between chronic infections, including periodontal infections, and cardiovascular disease. Dr. Angela Kamer, Assistant Professor of Periodontology & Implant Dentistry at New York University, led a research team that found a connection between periodontal disease and cognitive function, citing higher levels of antibodies and inflammatory molecules associated with periodontal disease in Alzheimer's patients over healthy people. The British Medical Journal posted a study conducted by researchers at Brown University stating that individuals with high levels of Porphyromonas gingivalis bacterium had twice as great a risk of developing pancreatic cancer over individuals with lower levels of these bacterium.
Oral care products traditionally have focused on taking either a specific kill of a bacterium or to indiscriminately kill all bacteria. This thinking needs to be replaced with an approach that improves the environment to change the bacterial balance in the mouth in a safe way that will have a healthier and more balanced affect long term.
The use of light and heat in oral care is known to kill bacteria in the 470-490 nm wavelength range. The use of light alone will have an impact specifically on p. gingivalis and to eliminate this bacteria.
We also know that the light and antibacterial approaches attacking the organisms will only have a short term effect.
What has not been used in the past is a mouthpiece with light and heat built inside, that creates a sealed gasket effect for any formulation that will be placed inside of it. It would be advantageous to couple a mouthpiece with a formulation that changes a gel to foam when warmed along with the mouthpiece that has light and heat installed therein. A universally shaped mouthpiece allows for a custom fit as its internal flex circuit shapes to the user's mouth when they bite down on its platform area.
It would be advantageous for the light and heat of a mouthpiece to activate a formulation to transform it from a gel to foam. Such a foam increases in volume and as contained in the closed system mouthpiece drives its active ingredients to the very difficult areas that require meticulous plaque control. These areas between the teeth, furthest areas back in the mouth and on the tongue, need this level of diligence.
In the prior art, post foaming agents are generally known which convert gel-like compositions to foam through application of heat. Post foaming agents are found in many personal care and over the counter products such as shampoos, conditioners, and activated skin treatments. When a post foaming gel is exposed to the combination of heat and light, the foaming agent is volatilized. During this process, thousands of tiny gas bubbles are created and interact with surfactants. A foaming rinse is typically created that delivers active ingredients of a formula incorporated into the post foaming gel to provide desired benefits.
Post foaming products known to Applicants utilize a blend of isopentane (C5H12) with a boiling point of 27.7° C. and isobutane (C4H10) with a boiling point of −11.7° C. as the foaming agent. The ratio of this blend can vary but it generally is 65% isopentane and 35% isobutane. The percentage of foaming agent in a product typically varies from 2% to 5%, or sometimes more depending upon the amount of foaming desired.
Applicants conducted laboratory and patient trials in which a foaming agent consisting of the combination of isopentane and isobutane was included in a proportion of 1% to 6%. These trials varied the percentage in one percent increments. Additionally, these trials varied the proportions of the constituent ingredients of the foaming agent so that the proportion of isopentane was varied from 50% to 85% in 5% increments.
Applicants analyzed the results of these laboratory and patient trials and concluded that none of the blends of foaming agent performed satisfactorily because, in each case, foaming occurred too quickly (at an unacceptably low temperature) and not consistently throughout application and use of the product. In this regard, the most advantageous scenario is for the post foaming gel to begin to foam only after it has been inserted into the oral cavity. These experimental products typically began to foam prior to insertion into the oral cavity.
Upon careful analysis, Applicants concluded that the reason the post foaming gel began to foam prior to insertion into the oral cavity was the presence of isobutane with its low boiling point (−11.7° C.). Accordingly, in formulating the inventive post foaming gel, isobutane was eliminated from the mixture and the post foaming agent comprises solely isopentane. Upon further experimentation, Applicants found that employing a post foaming agent solely comprising isopentane resulted in foaming action occurring only subsequent to insertion into the oral cavity.
People have always had trouble routinely brushing and flossing which keeps the bacteria in a healthy balance of good vs. bad bacteria. Once the plaque is allowed to form on the teeth close to the gums, over the course of just a few days, the bacterial microflora change to the more pathogenic anaerobes that cause disease. The oral care regimen needs to be easy to use, short in duration, healthy and safe long term, and must fit into people's lifestyles. In the past, minutes of brushing and 2 minutes to floss has not seen great success because of the technique sensitivity (user's ability) and the amount of time required to fit into people's busy lifestyles.
Applicants' original invention involves incorporation of light and heat to optimize the effectiveness of a whitening formulation by keeping the actives around longer and pushing them into the hard to reach areas to whiten. This mouthpiece has a warming element with a TPR or other thermoplastic material that warms, softens, and conforms to the mouth upon use to create a peripheral seal around the outside of the mouthpiece to seal actives inside. The universal mouthpiece, because of the flexible circuits, fits to any mouth, any arch form and the thermoplastic material forms the peripheral seal closed system.
The mouth is a dark, moist environment, where the hard to reach areas are void of oxygen, creating the perfect living headquarters for the anaerobic bacteria that thrive and cause the most damage.
It is known in the prior art to measure the level of acidity or basic characteristic within a person's mouth. However, Applicants are unaware of any prior art teaching measuring of the pH in the mouth of a user in the manner contemplated in the present invention. Applicants are aware of the following prior art:
U.S. Published Patent Applications2005/0113654 to Weber et al.2011/0053173 to Hood et al.2008/0233541 to De Vreese et al.2012/0123225 to Al-Tawil2009/0017422 to Creamer2012/0165694 to Meka et al.2009/0132011 to Altshuler et al.2012/0172677 to Logan et al.2009/0281433 to Saadat et al.2012/0172678 to Logan et al.2010/0081957 to Hyde et al.2012/0172679 to Logan et al.U.S. Patents5,674,182 to Suzuki et al.6,607,387 to Mault.
While each of these references teaches some aspect of sensing pH, none of them teaches the manner of doing so contemplated in the present invention.
Generally speaking, it is known in the prior art to utilize light at desired wavelengths to kill orally located germs. Applicants are aware of the following prior art references:
U.S. Published Patent Applications2004/0010299 to Tolkoff et al.2012/0021375 to Binner et al.2008/0032252 to Hayman et al.2012/0207806 to LoPesio.2012/0009539 to Goodson et al.U.S. Patents7,223,270 to Altshuler et al.7,329,274 to Altshuler et al.7,223,281 to Altshuler et al.7,354,448 to Altshuler et al.7,329,273 to Altshuler et al.7,422,598 to Altshuler et al.
The prior art references listed above generally disclose the use of light to kill bacteria, the use of light intra-orally, the use of the combination of mouthpieces and solutions to kill mouth bacteria, and the use of light in a toothbrush for oral phototherapy. Hayman et al. disclose use of a mouthpiece and use of light to kill bacteria.
While these references teach the concept of using light to kill bacteria in the mouth, in a general sense, none of these references taken alone or in combination with other references teaches or suggests the specific manner by which the present invention employs a mouthpiece, heat and light, and a foaming substance within a hermetically sealed environment to retain or restore an advantageous pH level within the mouth of a user to maintain oral health and general health.